自吸过滤式个体呼吸防护技术关键问题的研究
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摘要
我国环境质量报告书和世界资源报告提供的数据显示，近期我国空气质量超标的城市中，68％都存在可吸入颗粒物污染问题。个体减少通过呼吸系统吸入有害颗粒物最常用和最经济的技术措施是佩戴自吸过滤式防护口罩。然而，最常见的N95锥形(拱形)口罩、医用外科褶皱形口罩和平板型纱布口罩在佩带过程中的防护效果与预期性能存在一定差距。课题针对自吸过滤式个体呼吸防护技术体系中关键问题。完成的创新性工作、采用的方法和获得的结论如下。
对比分析了当前国内外关于自吸过滤式个体呼吸防护技术的标准规范，提出了美国NOISH标准84 CFR Part 84、欧洲标准委员会CEN标准EN149：2001和我国标准在测试自吸过滤式防护口罩防护性能技术指标的差异与不足。对比分析的结果在一定程度上提出了当前N95锥形(拱形)口罩、医用外科褶皱形口罩和平板型纱布口罩的技术指标存在的问题及解决方法，为提出适合我国国情的自吸过滤式个体呼吸防护设备的性能指标提供了参考。
为了与当前通用的标定装置TSI 8130进行对比，本课题设计了两套新型口罩过滤性能测试装置，并对多种市场常用自吸过滤式防护口罩过滤城市环境颗粒物的性能进行实验研究。通过对比实验，本文认为，纱布口罩低阻低效的过滤性能不理想：高孔隙率驻极体纤维滤料具有高效吸附微细颗粒物和低流体阻力的良好特性，适合用于防护口罩的滤材；板形结构使口罩与人体面部接触面积增大，密合度提高，适合用于无法实现密合设计和测试程序的简易防护口罩的结构。本文测试结果显示，N95锥形(拱形)口罩和医用外科褶皱形口罩的滤材过滤性能与佩戴时的防护性能差异较大，在佩戴时的防护效果与设计性能存在一定差距。
为分析自吸过滤式呼吸个体防护技术关键因素间的相互关系和综合影响效果，采用贝塔分布和泊松分布，建立了概率预测模型，可以在较少己知参数情况下，获得口罩佩戴者可能吸入有害颗粒物量等于或高于职业暴露限值(OEL)的概率。结果显示，长期佩戴N95口罩而可能吸入达到危害程度的有害颗粒物量的概率很高。另外，采用三因子分析方法，即口罩结构与人体密合因子(h-value)、阿尔法误差(α-error)和贝塔误差(β-error)建立口罩本体密合性能与测试评价模型。评价模型数据分析显示，对于人体样本可能被指定佩戴不合适口罩的概率来说，显然口罩结构与人体密合因子(h-value)的影响比贝塔误差(β-error)大；对于口罩密合测试方法的误差率来说，显然密合设计达标的口罩而没有通过密合测试的情况(阿尔法误差(α-error))影响比其它两个参数的影响大，结构与人体密合因子(h-value)的影响又远大于贝塔误差(β-error)。结果说明，在标定口罩密合性能测试中应该考虑口罩结构设计时的密合，而不合理的口罩密合测试方法会导致测试程序的复杂化。
为研究自吸过滤式防护口罩佩戴时的流场问题及口罩结构改进，采用计算机数值模拟的方法(CFD)模拟了人体模型佩戴自吸过滤式防护口罩时，由于不同边缘渗漏位置和形状而导致的口罩腔体内气流流场。结果显示条缝型渗漏对口罩佩戴在人头上，吸气过程中腔体内的流场影响更为显著。再者，鼻部渗漏可能引起其他位置渗漏的概率较大。另外，人体佩戴口罩由于吸气阻力较大而感觉气闷时，为有效地降低这种气闷感，本文认为干扰口罩佩戴状况而导致面颊产生渗漏的概率更大。因此，在设计口罩时，应根据有关密合测试组的尺寸特征，首先针对边缘增加高弹性与人体皮肤友好的材料，减小渗漏产生的概率：再者改进口罩顶部和底部的结构，减小鼻部渗漏和颌部渗漏的概率；最后针对整体结构优化，减少其它渗漏存在的概率，并且扩大口罩上半部分的腔体空间，有利于降低鼻部附近的湍流强度，减小产生渗漏的概率。
为了建立适合中国人面部特征的口罩密合测试组，用于自吸过滤式防护口罩的结构设计和密合测试，课题对比461名中国成年人面部尺寸数据和美国人、韩国人、澳洲人的面部特征尺寸，提出了不同人种面部特征尺寸的差异。研究认为中国人是否能够使用当前国外广泛使用的口罩密合测试组是值得做进一步研究。利用1988年中国国家标准调研数据验证课题提出的新型口罩密合测试组，结果证明新型密合测试组很好地代表了中国人样本面部特征尺寸，适用于中国人佩戴的口罩结构设计和口罩密合度测试。
课题还开发了新型自吸过滤式防护口罩产品并实现产业化，产生了较好的社会效益和经济效益。课题研究最后还提出了本领域研究的不足和未来研究方向。
论文研究不仅为中国人防御城市环境颗粒物污染的自吸过滤式呼吸防护技术提供了理论依据和应用指导，而且为其他人种在各种颗粒物污染环境中的个体呼吸防护技术发展提供了研究思路和发展方向。
Recently, more than sixty eight percents of cities in China had been attacked by particulate contaminant in munituple environment. For against such severe ambient particulate pollution and to prevent PM into respiratory system, donning self-inhalation filter type respirator may be a typical and economical protective measure. However, commercial N95 cup-type half-mask respirator and medical surgery folding respirator and gauze flat respiraor, while donned, maybe perform worse than expected. This study aims at key issues of self-inhalation filter type respiratory protective technology and demonstrates the original works with their methodologies and conclusions as the following.
Firstly, the study contrasts the surrent performance requirements for testing simple respirator oversea and in China. The differences between those standards such as 84 CFR Part 84 (NIOSH) and EN149:2001 (EU) and requirements in China, show that those certified commercial self-inhalation filter type respirators, which are,N95 respirator and medical surgery respiator and gauze respirator, may perform unexpectedly firstly because of the undevelopment of certification index for performance testing. The contrasted results propose the references for developing new performance indexes applicable to China.
Secondly, one of the widely recognized methodologies for testing respirator media is using TSI 8130 as test equipment and NaCL or DOP as test challenges. Basing on the analysis of TSI 8130, this study constructs two new systems for testing the protective performance of respirator against ambient aerosols. The results of analysis show that the performance of gauze respirators were so bad that many layers of gauze respirator may not protect persons from infection. On the other hand, high porosity electret fiber media with high efficient and low resistance against ambient aerosols may be the relatively optimal filter media for respirators. Additionally, the flat-type of respirator meant that more surfaces of filter media could be sealed to subjects' skin and the fit factor could be increased. So, flat-type may be the optimal profile for respirators.
Fourthly, this study structures a new probability prediction model for fit performance of respirator donned on a group of subjects basing on beta distribution and Poisson distribution. The . new prediction model uses a small number of parameters to predict the probability of the mass quantity of particulate contaminants being higher than occupational exposure limit. The results from the prediction model show that subjects donning a respirator for a long time may inhale hazardous dose of particulate contaminants in a great probability, which is 44% for three subjects. Furthermore, three values, which are h-value,α-error andβ-error, are used to structure fit performance and test evaluation model to assess the fit performance of respirator and the accuracy of fit test methodology. The results from the evaluation model show that h-value affects the probability of assigned inadequate fit respirator more thanβ-error. Otherwise,α-error affects the test methodology accuracy more significant than other two values. Among h-value andβ-error, the former impacts the test methodology accuracy more than the latter. As a conclusion, NIOSH's standards without considering the fit character of respirator may be unreasonable and will result in complication of respirator test program.
Fifthly, the pressure and velocity in the chamber between the respirator and the face in inhaling period have been simulated by CFD methodology. The pressure and velocity field with half-circle or gap leakage and without leakage are analyzed in contrast. The results illustrate that gap leakage affects the field more significant that half-circle leakage. Moreover, cheek leakage may markedly decrease the stivy feeling of respirator wearers. Those conclusions propose that the optimal respirators be designed in accordance with fit test panel and equipped with elasticated materials on their edge, and improved their top and bottom structure. At last, the top half-chamber of respirator should be elaborately improved in order to reduce the leakages.
Lastly, this study compares data of facial anthropometric dimensions for 461 Chinese subjects and for other race/ethnic groups, such as American and Korean and Australian. A new respirator fit test panel must be structured for Chinese because the differences in the facial size between those races are so significant that the current respirator fit test panels are not be applicable to Chinese. The data from 1988 Chinese adult facial size survey are utilized for evaluating the applicability of new respirator fit test panel for Chinese. The results show that the new respirator fit test panel proposed by this study can accommodate the most of data from the facial anthropometric survey in the study and can be applicable to Chinese for respirator designing and fit testing.
Basing on the conclusions, a new type respirators had been designed and been brought about industrialization, which shown a good social significance. Finally, this study also proposed disadvantages of the research and the trend for their development.
This study used ambient aerosols as the challenge and developed the new self-inhalation filter type respiratory protective technology, which not only applicable to Chinese but also to other races. As a whole, the results of this research show a good scientific significance and technological innovation.
对比分析了当前国内外关于自吸过滤式个体呼吸防护技术的标准规范，提出了美国NOISH标准84 CFR Part 84、欧洲标准委员会CEN标准EN149：2001和我国标准在测试自吸过滤式防护口罩防护性能技术指标的差异与不足。对比分析的结果在一定程度上提出了当前N95锥形(拱形)口罩、医用外科褶皱形口罩和平板型纱布口罩的技术指标存在的问题及解决方法，为提出适合我国国情的自吸过滤式个体呼吸防护设备的性能指标提供了参考。
为了与当前通用的标定装置TSI 8130进行对比，本课题设计了两套新型口罩过滤性能测试装置，并对多种市场常用自吸过滤式防护口罩过滤城市环境颗粒物的性能进行实验研究。通过对比实验，本文认为，纱布口罩低阻低效的过滤性能不理想：高孔隙率驻极体纤维滤料具有高效吸附微细颗粒物和低流体阻力的良好特性，适合用于防护口罩的滤材；板形结构使口罩与人体面部接触面积增大，密合度提高，适合用于无法实现密合设计和测试程序的简易防护口罩的结构。本文测试结果显示，N95锥形(拱形)口罩和医用外科褶皱形口罩的滤材过滤性能与佩戴时的防护性能差异较大，在佩戴时的防护效果与设计性能存在一定差距。
为分析自吸过滤式呼吸个体防护技术关键因素间的相互关系和综合影响效果，采用贝塔分布和泊松分布，建立了概率预测模型，可以在较少己知参数情况下，获得口罩佩戴者可能吸入有害颗粒物量等于或高于职业暴露限值(OEL)的概率。结果显示，长期佩戴N95口罩而可能吸入达到危害程度的有害颗粒物量的概率很高。另外，采用三因子分析方法，即口罩结构与人体密合因子(h-value)、阿尔法误差(α-error)和贝塔误差(β-error)建立口罩本体密合性能与测试评价模型。评价模型数据分析显示，对于人体样本可能被指定佩戴不合适口罩的概率来说，显然口罩结构与人体密合因子(h-value)的影响比贝塔误差(β-error)大；对于口罩密合测试方法的误差率来说，显然密合设计达标的口罩而没有通过密合测试的情况(阿尔法误差(α-error))影响比其它两个参数的影响大，结构与人体密合因子(h-value)的影响又远大于贝塔误差(β-error)。结果说明，在标定口罩密合性能测试中应该考虑口罩结构设计时的密合，而不合理的口罩密合测试方法会导致测试程序的复杂化。
为研究自吸过滤式防护口罩佩戴时的流场问题及口罩结构改进，采用计算机数值模拟的方法(CFD)模拟了人体模型佩戴自吸过滤式防护口罩时，由于不同边缘渗漏位置和形状而导致的口罩腔体内气流流场。结果显示条缝型渗漏对口罩佩戴在人头上，吸气过程中腔体内的流场影响更为显著。再者，鼻部渗漏可能引起其他位置渗漏的概率较大。另外，人体佩戴口罩由于吸气阻力较大而感觉气闷时，为有效地降低这种气闷感，本文认为干扰口罩佩戴状况而导致面颊产生渗漏的概率更大。因此，在设计口罩时，应根据有关密合测试组的尺寸特征，首先针对边缘增加高弹性与人体皮肤友好的材料，减小渗漏产生的概率：再者改进口罩顶部和底部的结构，减小鼻部渗漏和颌部渗漏的概率；最后针对整体结构优化，减少其它渗漏存在的概率，并且扩大口罩上半部分的腔体空间，有利于降低鼻部附近的湍流强度，减小产生渗漏的概率。
为了建立适合中国人面部特征的口罩密合测试组，用于自吸过滤式防护口罩的结构设计和密合测试，课题对比461名中国成年人面部尺寸数据和美国人、韩国人、澳洲人的面部特征尺寸，提出了不同人种面部特征尺寸的差异。研究认为中国人是否能够使用当前国外广泛使用的口罩密合测试组是值得做进一步研究。利用1988年中国国家标准调研数据验证课题提出的新型口罩密合测试组，结果证明新型密合测试组很好地代表了中国人样本面部特征尺寸，适用于中国人佩戴的口罩结构设计和口罩密合度测试。
课题还开发了新型自吸过滤式防护口罩产品并实现产业化，产生了较好的社会效益和经济效益。课题研究最后还提出了本领域研究的不足和未来研究方向。
论文研究不仅为中国人防御城市环境颗粒物污染的自吸过滤式呼吸防护技术提供了理论依据和应用指导，而且为其他人种在各种颗粒物污染环境中的个体呼吸防护技术发展提供了研究思路和发展方向。
Recently, more than sixty eight percents of cities in China had been attacked by particulate contaminant in munituple environment. For against such severe ambient particulate pollution and to prevent PM into respiratory system, donning self-inhalation filter type respirator may be a typical and economical protective measure. However, commercial N95 cup-type half-mask respirator and medical surgery folding respirator and gauze flat respiraor, while donned, maybe perform worse than expected. This study aims at key issues of self-inhalation filter type respiratory protective technology and demonstrates the original works with their methodologies and conclusions as the following.
Firstly, the study contrasts the surrent performance requirements for testing simple respirator oversea and in China. The differences between those standards such as 84 CFR Part 84 (NIOSH) and EN149:2001 (EU) and requirements in China, show that those certified commercial self-inhalation filter type respirators, which are,N95 respirator and medical surgery respiator and gauze respirator, may perform unexpectedly firstly because of the undevelopment of certification index for performance testing. The contrasted results propose the references for developing new performance indexes applicable to China.
Secondly, one of the widely recognized methodologies for testing respirator media is using TSI 8130 as test equipment and NaCL or DOP as test challenges. Basing on the analysis of TSI 8130, this study constructs two new systems for testing the protective performance of respirator against ambient aerosols. The results of analysis show that the performance of gauze respirators were so bad that many layers of gauze respirator may not protect persons from infection. On the other hand, high porosity electret fiber media with high efficient and low resistance against ambient aerosols may be the relatively optimal filter media for respirators. Additionally, the flat-type of respirator meant that more surfaces of filter media could be sealed to subjects' skin and the fit factor could be increased. So, flat-type may be the optimal profile for respirators.
Fourthly, this study structures a new probability prediction model for fit performance of respirator donned on a group of subjects basing on beta distribution and Poisson distribution. The . new prediction model uses a small number of parameters to predict the probability of the mass quantity of particulate contaminants being higher than occupational exposure limit. The results from the prediction model show that subjects donning a respirator for a long time may inhale hazardous dose of particulate contaminants in a great probability, which is 44% for three subjects. Furthermore, three values, which are h-value,α-error andβ-error, are used to structure fit performance and test evaluation model to assess the fit performance of respirator and the accuracy of fit test methodology. The results from the evaluation model show that h-value affects the probability of assigned inadequate fit respirator more thanβ-error. Otherwise,α-error affects the test methodology accuracy more significant than other two values. Among h-value andβ-error, the former impacts the test methodology accuracy more than the latter. As a conclusion, NIOSH's standards without considering the fit character of respirator may be unreasonable and will result in complication of respirator test program.
Fifthly, the pressure and velocity in the chamber between the respirator and the face in inhaling period have been simulated by CFD methodology. The pressure and velocity field with half-circle or gap leakage and without leakage are analyzed in contrast. The results illustrate that gap leakage affects the field more significant that half-circle leakage. Moreover, cheek leakage may markedly decrease the stivy feeling of respirator wearers. Those conclusions propose that the optimal respirators be designed in accordance with fit test panel and equipped with elasticated materials on their edge, and improved their top and bottom structure. At last, the top half-chamber of respirator should be elaborately improved in order to reduce the leakages.
Lastly, this study compares data of facial anthropometric dimensions for 461 Chinese subjects and for other race/ethnic groups, such as American and Korean and Australian. A new respirator fit test panel must be structured for Chinese because the differences in the facial size between those races are so significant that the current respirator fit test panels are not be applicable to Chinese. The data from 1988 Chinese adult facial size survey are utilized for evaluating the applicability of new respirator fit test panel for Chinese. The results show that the new respirator fit test panel proposed by this study can accommodate the most of data from the facial anthropometric survey in the study and can be applicable to Chinese for respirator designing and fit testing.
Basing on the conclusions, a new type respirators had been designed and been brought about industrialization, which shown a good social significance. Finally, this study also proposed disadvantages of the research and the trend for their development.
This study used ambient aerosols as the challenge and developed the new self-inhalation filter type respiratory protective technology, which not only applicable to Chinese but also to other races. As a whole, the results of this research show a good scientific significance and technological innovation.
引文
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